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FDA 510(k)

NeuMoDx GBS Assay

K-Number: K173725 · 2018-06-26

ApplicantNeumodx Molecular, Inc.
Decision Date2018-06-26
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NeuMoDx GBS Assay is a medical device manufactured by Neumodx Molecular, Inc.. It received FDA 510(k) clearance on 2018-06-26 under approval number K173725. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuMoDx GBS Assay?

NeuMoDx GBS Assay is a medical device that received FDA 510(k) clearance on 2018-06-26. It is manufactured by Neumodx Molecular, Inc.. The 510(k) number is K173725.

When was NeuMoDx GBS Assay approved by the FDA?

NeuMoDx GBS Assay received FDA 510(k) clearance on 2018-06-26, under approval number K173725.

What company makes NeuMoDx GBS Assay?

NeuMoDx GBS Assay is manufactured by Neumodx Molecular, Inc..

What is the FDA product code for NeuMoDx GBS Assay?

The FDA product code for NeuMoDx GBS Assay is NJR.

Other Devices by Neumodx Molecular, Inc.

K230267NeuMoDx CT/NG Assay 2.0

Related Devices (Code: NJR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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